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This study will explore the use of flortaucipir as a biomarker for chronic traumatic encephalopathy (CTE) and examine the relationship between clinical presentation and tau deposition.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| High Risk of CTE | Experimental | Flortaucipir PET scans in subjects at high risk of developing CTE (former National Football League players) |
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| Control | Experimental | Flortaucipir PET scans in former non-contact athletes |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| florbetapir F 18 | Drug | 370 megabecquerel (MBq) IV single-dose |
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| Measure | Description | Time Frame |
|---|---|---|
| Flortaucipir Visual Read as CTE Biomarker | Flortaucipir uptake was rated visually by sponsor expert reader as 'No Uptake', 'Mild Uptake', 'Moderate Uptake', or 'Intense Uptake'. | Baseline scan |
| Relationship Between Clinical Presentation and Tau Deposition (Subjects at High Risk of CTE Only) | The relationship between flortaucipir uptake and clinical presentation, as measured by the Mini-Mental State Examination (MMSE). Mini-mental status exam is a 30-point questionnaire that is used to measure cognitive impairment. Scores range from 0 to 30 with lower scores representing greater levels of cognitive impairment. Specified in statistical analysis plan to only be conducted in High Risk of CTE group. | baseline scan |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Chief Medical Officer | Avid Radiopharmaceuticals, Inc. | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Banner Alzheimer's Institute | Phoenix | Arizona | 85006 | United States | ||
| Boston University |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30969506 | Result | Stern RA, Adler CH, Chen K, Navitsky M, Luo J, Dodick DW, Alosco ML, Tripodis Y, Goradia DD, Martin B, Mastroeni D, Fritts NG, Jarnagin J, Devous MD Sr, Mintun MA, Pontecorvo MJ, Shenton ME, Reiman EM. Tau Positron-Emission Tomography in Former National Football League Players. N Engl J Med. 2019 May 2;380(18):1716-1725. doi: 10.1056/NEJMoa1900757. Epub 2019 Apr 10. |
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Subjects were recruited between June 2014 and October 2015 from the DETECT study (National Institutes of Health grant R01NS078337) and the Arizona Alzheimer's Consortium ("Long-Term Consequences of Repetitive Brain Injury in Athletes: A Longitudinal Study with Eventual Brain Donation")
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| ID | Title | Description |
|---|---|---|
| FG000 | High Risk of CTE | Subjects at high risk of developing CTE (chronic traumatic encephalopathy) - former National Football League players |
| FG001 | Controls | Former non-contact athletes |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Flortaucipir F18 | Drug | 370 megabecquerel (MBq) IV single-dose |
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| Boston |
| Massachusetts |
| 02118 |
| United States |
| COMPLETED |
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| NOT COMPLETED |
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Includes all subjects who received at least one dose of florbetapir or flortaucipir
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| ID | Title | Description |
|---|---|---|
| BG000 | High Risk of CTE | Subjects at high risk of developing CTE (former National Football League players) |
| BG001 | Controls | Former non-contact athletes |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| MMSE | Mini-mental status exam is a 30-point questionnaire that is used to measure cognitive impairment. Scores range from 0 to 30 with lower scores representing greater levels of cognitive impairment. | Mean | Standard Deviation | units on a scale |
| ||||||||||||||
| Amyloid status | Measured by flortaucipir PET scan visual read augmented with quantitative information | Only included subjects for which a florbetapir PET scan was available | Count of Participants | Participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Flortaucipir Visual Read as CTE Biomarker | Flortaucipir uptake was rated visually by sponsor expert reader as 'No Uptake', 'Mild Uptake', 'Moderate Uptake', or 'Intense Uptake'. | All subjects who received a flortaucipir scan | Posted | Count of Participants | Participants | Baseline scan |
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| Primary | Relationship Between Clinical Presentation and Tau Deposition (Subjects at High Risk of CTE Only) | The relationship between flortaucipir uptake and clinical presentation, as measured by the Mini-Mental State Examination (MMSE). Mini-mental status exam is a 30-point questionnaire that is used to measure cognitive impairment. Scores range from 0 to 30 with lower scores representing greater levels of cognitive impairment. Specified in statistical analysis plan to only be conducted in High Risk of CTE group. | Only subjects at high risk for CTE were included in this analysis | Posted | Least Squares Mean | 95% Confidence Interval | score on a scale | baseline scan |
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End of study for AE reporting was 48 hours after the last study drug administration.
Adverse events (AEs) were collected at scan visits, regardless of attribution to study drug. AEs occurring after study drug administration, but outside that window were not recorded, unless considered attributable to either drug. Includes all subjects who received at least one dose of florbetapir or flortaucipir
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | High Risk of CTE | Subjects at high risk of developing CTE (former National Football League players) | 0 | 29 | 0 | 29 | 11 | 29 |
| EG001 | Controls | Former non-contact athletes | 0 | 11 | 0 | 11 | 5 | 11 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| headache | Nervous system disorders | MedDRA 17.1 | Systematic Assessment |
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| nausea | Gastrointestinal disorders | MedDRA 17.1 | Systematic Assessment |
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| oral pain | Gastrointestinal disorders | MedDRA 17.1 | Systematic Assessment |
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| muscle spasms | Musculoskeletal and connective tissue disorders | MedDRA 17.1 | Systematic Assessment |
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| dizziness | Nervous system disorders | MedDRA 17.1 | Systematic Assessment |
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| diarrhoea | Gastrointestinal disorders | MedDRA 17.1 | Systematic Assessment |
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| musculoskeletal discomfort | Musculoskeletal and connective tissue disorders | MedDRA 17.1 | Systematic Assessment |
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| fatigue | General disorders | MedDRA 17.1 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Medical Director | Avid Radiopharmaceuticals, Inc. | 215-298-0700 | clinicaloperations@avidrp.com |
| ID | Term |
|---|---|
| D000070627 | Chronic Traumatic Encephalopathy |
| ID | Term |
|---|---|
| D000070642 | Brain Injuries, Traumatic |
| D001930 | Brain Injuries |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D020208 | Brain Injury, Chronic |
| D019636 | Neurodegenerative Diseases |
| D006259 | Craniocerebral Trauma |
| D020196 | Trauma, Nervous System |
| D001925 | Brain Damage, Chronic |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D014947 | Wounds and Injuries |
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| ID | Term |
|---|---|
| C545186 | florbetapir |
| C000591008 | 7-(6-fluoropyridin-3-yl)-5H-pyrido(4,3-b)indole |
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| Moderate Uptake |
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| Intense Uptake |
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